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coflex® Interlaminar Stabilization®

The 1ST and Only Motion Preserving Minimally Invasive Treatment Approved for Moderate to Severe Spinal Stenosis After Decompression

The coflex® Interlaminar Technology is an Interlaminar Stabilization® device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. The Interlaminar Stabilization® device is implanted after decompression of stenosis at the affected level(s). Please see Instructions for Use for complete list of warnings, precautions and contraindications.

A brief overview of information related to FDA’s approval to market coflex®, as well as links to the Summary of Safety and Effectiveness Data (SSED) and product labeling can be accessed by visiting the following link:

Thecoflex® Interlaminar Technology Design

The coflex® device consists of a single, U-shaped component, made from medical-grade titanium alloy, a material with a long history of safe use in implantable orthopedic products. In clinical use, the “U” is positioned horizontally, with its apex oriented anteriorly and the two long arms of the “U” paralleling the long axis of the spinous processes. The bone-facing surfaces are ridged to provide resistance to migration.